Abstract Preview

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

—    details of in vivo skin sensitization test procedures;

—    key factors for the interpretation of the results.

NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

General information

  • Status :  Published
    Publication date : 2021-11
  • Edition : 4
    Number of pages : 48
  • :
    ISO/TC 194
    Biological and clinical evaluation of medical devices
  • 11.100.20
    Biological evaluation of medical devices

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